Food And Drug Administration

Dispatches from AAPS

Emerging market CMOs and their customers must make info easily available: FDA

16-Oct-2012 By Natalie Morrison

Make information about generic production readily available when working with vendors in emerging markets for quicker US approval, says the FDA.

EXCLUSIVE

EMA biosimilar guidance welcomed but has further to go, say EGA, Aptuit and Charles River

04-Oct-2012 By Natalie Morrison

Latest EMA biosimilar guidance on reference products is a “major breakthrough” but there is still work to do, say industry experts.

BPTF says FDA safety and innovation act is good for safety and US industry

11-Jul-2012 By Gareth Macdonald

SOCMA’s BPTF says new fee laws under the FDA Safety and Innovation Act will improve drug quality and boost US manufacturing sector.

EMA adds formulation, closure flexibility to biosimilar guidance

05-Jun-2012 By Nick Taylor

The EMA has joined the FDA in proposing to accept different biosimilar formulations and closures in revised draft guidelines.

US Senate votes on FDA safety and innovation act

23-May-2012 By Gareth Macdonald

The US FDA will have more powers to inspect ‘risky’ overseas pharmaceutical plants according to supporters of a bill being considered by the US senate this week. 

News from Novasep, BioTime and Syndax – People on the move

24-Apr-2012 By Natalie Morrison

in-PharmaTechnologist presents its weekly round-up of the latest climbers on the pharmaceutical career ladder, including news from Novasep, BioTime and Syndax.

Chinese service provider files $80m IPO to fund expansion

28-Feb-2012 By Nick Taylor

A Chinese company that offers drug development services using a network of 99 third-party vendors has filed an $80m IPO.

Trade secret changes critical to regulatory sharing, FDA says

14-Feb-2012 By Nick Taylor

The FDA has said it is critical that trade secret laws are changed to allow it to share manufacturing information with other regulators.

Contract manufacturing round-up

26-Jan-2012 By Natalie Morrison

Outsourcing-Pharma presents a round-up of the latest headlines within the world of contract manufacturing. Catalent and Patheon have each launched oral dosage partnership news, whilst Frontage and AMPAC have received regulatory go-aheads.

FDA & EMA plant approvals to cut bottlenecks at Genzyme

24-Jan-2012 By Nick Taylor

The FDA has followed the EMA in approving the Framingham, MA plant that Genzyme hopes will cut production bottlenecks.

FDA plans overseas inspections as GDUFA goes to Congress

16-Jan-2012 By Nick Taylor

The US FDA has sent its generic user fee recommendations to Congress ahead of a meeting to discuss the plan next month.

PhRMA backs FDA plans for biosimilar fees discussion

07-Dec-2011 By Gareth Macdonald

US drug industry group PhRMA has backed FDA plans to discuss fees for biosimilars with pharmaceutical manufacturers.

FDA releases draft co-crystal guidance to support NDAs

05-Dec-2011 By Nick Taylor

The US FDA has published draft guidance to help companies submit marketing applications for API-excipient co-crystals.

News from AstraZeneca, Apricus, and BioTime – People on the move

01-Dec-2011 By Natalie Morrison

in-PharmaTechnologist presents its round-up of the latest career moves within the world of pharmaceuticals, including news from AstraZeneca, Apricus, and BioTime.

Round up of CMO deals

19-Jul-2011 By Nick Taylor

Outsourcing-Pharma presents a round up of recent contract manufacturing deals, including business at Lonza, JHP Pharmaceuticals and PCT.

NeoStem’s China antibiotics unit gets expanded SFDA approval

14-Jun-2011 By Gareth Macdonald

US stem-cell therapy firm NeoStem predicts that output of its China-based generic antibiotics subsidiary Suzhou Erye Pharmaceutical will increase after further manufacturing approval from the SFDA.

Biobetter biotechs emerge as preclinical services clients

16-May-2011 By Nick Taylor

Biotechs set up to take an existing biologic, improve it and license the resulting biobetter are an emerging client for preclinical service providers.

West to add CZ vials as glass QC issues drive interest

01-Dec-2010 By Nick Taylor

Recognition of glass vial quality issues is supporting interest in West’s analytical capabilities and Crystal Zenith (CZ) products, new sizes of which are being developed, said a company VP.

China's API players have bright 'potential future'

07-Oct-2010 By Nick Taylor

China leads the field in 'potential future' API suppliers, positioning it to become a dominant force as these companies develop, Thomson Reuters said at CPhI 2010.

Cali OK for Avrio manufacturing plant

11-Feb-2010 By Staff Reporter

US CDMO Avrio Biopharmaceuticals’ new aseptic fill-and-finish facility in Irvine, California has been approved for the manufacture of biologics by state drug regulators.

ACRO wants trials for most biosimilars

15-Oct-2009 By Gareth Macdonald

ACRO says while a 12-year exclusivity period for innovative drugs is important for R&D, US legislation should include rules on trials for biosimilars

WHO urged to change biologic drug naming policy

22-Nov-2006 By Kirsty Barnes

The Biotechnology Industry Organization (BIO) urged the World
Health Organization (WHO) to change its International
Nonproprietary Names (INN) policy for biological products at a
meeting last week in Geneva.

Time for FDA to move on biogenerics

21-Mar-2005

As the US Food and Drug Administration continues its deliberations
on generic biopharmaceuticals, the industry body representing
generic drug manufacturers has said that the time has now come for
the agency to make some hard decisions,...

Boehringer plant cleared by FDA

08-Jul-2004

Germany's Boehringer Ingelheim has completed the validation process
for its new biopharmaceutical production plant in Biberach with a
positive inspection by the US Food and Drug Administration (FDA).