On Thursday, FDA published the final guidance document, “Determining Whether to Submit an ANDA or a 505(b)(2) Application” that contains minor revisions to the October 2017 draft guidance. ...more
Faster review periods and waiver of requirement for Chinese clinical trials are intended to encourage marketing applications -
On 28 March China's National Medical Products Administration (NMPA) published a list of an...more
Read the latest news on antitrust, competition and economic regulation (ACER) in this Winter's edition of our quarterly ACER newsletter.
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4/3/2019
/ Antitrust Provisions ,
Bid Rigging ,
CFIUS ,
Economic Development ,
EU ,
Federal Trade Commission (FTC) ,
Foreign Direct Investment ,
Government Shutdown ,
Hold-Separate Remedies ,
Merger Controls ,
No-Poaching ,
Pharmaceutical Patents ,
Public Procurement Policies ,
Regulatory Standards ,
South Africa ,
UK Competition and Markets Authority (CMA)
Wednesday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the D.C. Circuit Court in Eagle...more
2/22/2019
/ Abbreviated New Drug Application (ANDA) ,
FDA Approval ,
FDA Reauthorization Act ,
FDARA ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Healthcare ,
Life Sciences ,
Orphan Drugs ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Exclusivity ,
Regulatory Agenda ,
Regulatory Oversight ,
Reversal
On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level information on ways to bring combination products to market....more
On January 4, China’s National People’s Congress (NPC) released draft amendments to the Chinese Patent Law, proposing expanded and enhanced protections that may provide real benefits to companies that develop new drugs. ...more
The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019. Unfortunately, FDA is one of the agencies with at least some...more
12/28/2018
/ Center for Drug Evaluation and Research (CDER) ,
Federal Budget ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
Healthcare ,
Medical Devices ,
Pharmaceutical Industry ,
Premarket Approval Applications ,
Public Health ,
Regulatory Agenda ,
Regulatory Oversight ,
Trump Administration
Yesterday, FDA released a series of guidances that aim to advance the agency’s biosimilars policy framework, along with a proposed rule on the definition of a “biological product,” which incorporates changes made by the...more
On 8 August 2018, in an unprecedented regulatory action, the China National Drug Administration (CNDA) called on international pharmaceutical companies to bring 48 new drugs to China. These new drugs are viewed to be urgently...more
This is the first time the China Drug Administration (CDA) provides details on how the data exclusivity applies to pre-clinical and clinical data submitted to the agency. Companies with plans to launch pharmaceutical products...more